Humacyte Inc (HUMA) 2025 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Humacyte first quarter results conference call. (Operator Instructions) As a reminder, this conference is being recorded.

女士們、先生們，早安，歡迎參加 Humacyte 第一季業績電話會議。（操作員指示）提醒一下，本次會議正在錄音。

I will now turn the conference call over to Tom Johnson with LifeSci Advisors. Please go ahead, sir.

現在我將電話會議轉給 LifeSci Advisors 的湯姆·約翰遜。先生，請繼續。

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historic experience or present expectations.

謝謝您，接線生。在我們繼續電話會議之前，我想提醒大家，根據美國聯邦證券法，本次電話會議中所做的某些聲明屬於前瞻性聲明。這些聲明受風險和不確定性的影響，可能導致實際結果與歷史經驗或當前預期有重大差異。

Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of date hereof, and the company undertakes no obligation to update or revise the forward-looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the Investor page of the Humacyte website.

有關可能導致實際結果與本次電話會議中的陳述不同的因素的更多信息，包含在我們向美國證券交易委員會提交的定期報告中。本次電話會議中所做的前瞻性陳述僅代表截至本電話會議之日的觀點，除非法律要求，否則本公司不承擔更新或修改前瞻性陳述的義務。本次電話會議中提供的資訊包含在我們今天早上發布的新聞稿和我們的 10-Q 表中，提交後可從 Humacyte 網站的投資者頁面訪問。

Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and BJ Scheessele, Chief Commercial Officer. Dr. Niklason will provide a summary of the company's progress for the first quarter and recent weeks, and Dale will review the financial results for the quarter ended March 31, 2025. Following their prepared remarks, BJ will join Laura and Dale for the Q&A session.

今天與我一起參加 Humacyte 電話會議的還有總裁兼執行長 Laura Niklason 博士、財務長兼首席企業發展長 Dale Sander 以及商務長 BJ Scheessele。Niklason 博士將總結公司第一季和最近幾週的進展情況，Dale 將回顧截至 2025 年 3 月 31 日的季度財務業績。在準備好的發言之後，BJ 將與 Laura 和 Dale 一起參加問答環節。

I will now turn the call over to Dr. Niklason. Laura?

現在我將把電話轉給尼克拉森博士。勞拉？

Thank you, Tom, and good morning, everyone, and thank you for joining us for our first quarter 2025 financial results and business update call. Following the landmark success of obtaining FDA approval of Symvess for the treatment of extremity vascular trauma late last year, we're keenly focused on the commercial launch of this groundbreaking product.

謝謝你，湯姆，大家早安，謝謝你們參加我們 2025 年第一季的財務表現和業務更新電話會議。繼去年年底 Symvess 獲得 FDA 批准用於治療肢體血管創傷並取得里程碑式的成功之後，我們全神貫注於這項突破性產品的商業化發布。

Supporting the launch is our number one priority, and we're pleased by the traction gained in our interactions with hospitals despite the current volatile economic environment. Based upon our March 2025 financing and some recent cost reductions, we've taken steps to extend Humacyte's cash runway.

支持此次發布是我們的首要任務，儘管當前經濟環境動盪，但我們與醫院的互動取得了進展，對此我們感到很高興。根據我們 2025 年 3 月的融資和最近的一些成本削減，我們已採取措施延長 Humacyte 的現金流。

With this extended runway, we'll continue to aggressively expand our commercial launch while creating additional enterprise value from our bioengineering pipeline.

透過這條延長的跑道，我們將繼續積極擴大我們的商業發布，同時從我們的生物工程管道中創造額外的企業價值。

Upcoming major value drivers that we anticipate include publication of additional clinical results in trauma and in dialysis access and filing an IND with the FDA later this year to enable first-in-human clinical testing of our small diameter ATEV in coronary artery bypass grafting.

我們預計即將出現的主要價值驅動因素包括發布創傷和透析通路方面的更多臨床結果，並在今年稍後向 FDA 提交 IND，以便在冠狀動脈搭橋術中首次對我們的小直徑 ATEV 進行人體臨床試驗。

In addition, as a result of reaching a major milestone in enrollment in our V012 Phase III trial in dialysis, we're also on track for filing a supplemental BLA for the ATEV in dialysis in 2026.

此外，由於我們在透析領域的 V012 III 期試驗中達到了招募的重要里程碑，我們也預計在 2026 年為透析領域的 ATEV 提交補充 BLA。

During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. BJ Scheessele, our Chief Commercial Officer, will then join us to help answer your questions.

在今天的電話會議中，我將更詳細地回顧這些發展情況，然後將電話轉給戴爾審查我們的財務結果。我們的首席商務長 BJ Scheessele 將加入我們，協助解答您的問題。

As I start the review of the quarter, I want to acknowledge the strong support that we've had from surgeons who have treated patients with Symvess and the resiliency of our team members in the face of some unfounded negative press regarding Symvess and Humacyte.

在我開始回顧本季時，我想感謝那些使用 Symvess 治療患者的外科醫生給予我們的大力支持，以及我們的團隊成員在面對有關 Symvess 和 Humacyte 的一些毫無根據的負面報道時所表現出的韌性。

As you probably know, we've addressed these critiques in public statements in recent weeks. In short, we believe that these criticisms are ill-informed and without merit.

您可能知道，我們最近幾週已在公開聲明中回應了這些批評。簡而言之，我們認為這些批評是錯誤的，毫無根據的。

Over the last two decades, we've worked hard to build Humacyte into what it is today. The body of clinical results supporting the use of Symvess in extremity vascular trauma will be further strengthened by upcoming publication in peer-reviewed medical journals of our long-term patient outcomes. We will continue to combat unfounded attacks with science-based facts.

在過去的二十年裡，我們努力將 Humacyte 打造成今天的樣子。我們即將在同行評審的醫學期刊上發表長期患者結果，這將進一步加強支持使用 Symvess 治療肢體血管創傷的臨床結果。我們將繼續用基於科學的事實來打擊毫無根據的攻擊。

With that out of the way, I'm proud to report that Humacyte commenced its commercial launch of Symvess in late February 2025. The first commercial shipments containing multiple units of Symvess were made during the first quarter to 3 Level 1 trauma centers.

有了這些，我很自豪地報告，Humacyte 於 2025 年 2 月下旬開始商業推出 Symvess。第一季度，首批包含多台 Symvess 的商業貨物已運往 3 家一級創傷中心。

As a reminder, commencement of sales to hospitals for new products typically requires review and approval by a Value Analysis Committee, or VAC, which is a centralized decision-making body within the institution. Only a few months after commercial launch, we're excited that 45 hospitals have already commenced an evaluation of Symvess as part of their VAC approval process, approximately 1/4 of all Level 1 trauma centers nationwide.

提醒一下，向醫院銷售新產品通常需要價值分析委員會（VAC）的審查和批准，該委員會是機構內的集中決策機構。在商業推出僅幾個月後，我們很高興地看到，45 家醫院已經開始對 Symvess 進行評估，作為其 VAC 批准流程的一部分，約佔全國所有一級創傷中心的 1/4。

The VACs of five hospitals have already approved the purchase of Symvess, and we expect this number to grow throughout the second quarter based on current discussions with hospitals. Our commercial launch of Symvess is further supported by publication in March 2025 of our Budget Impact Model in the peer-reviewed Journal of Medical Economics.

五家醫院的 VAC 已經批准購買 Symvess，根據目前與醫院的討論，我們預計這一數字將在第二季度增長。我們將於 2025 年 3 月在同行評審的《醫學經濟學雜誌》上發表預算影響模型，進一步支持 Symvess 的商業化發布。

This publication shows that Symvess provides economic value to the health care system. By reducing conduit infections and limb amputations, Symvess provides a strong opportunity for cost reduction as compared to synthetic conduits and as compared to xenografts and the like.

該出版物表明 Symvess 為醫療保健系統提供了經濟價值。透過減少導管感染和截肢，與合成導管和異種移植等相比，Symvess 提供了降低成本的強大機會。

In addition to the civilian market, Humacyte has been working to address the military market for Symvess in extremity vascular trauma. Multiple military treatment facilities have already expressed an interest in purchasing Symvess.

除了民用市場之外，Humacyte 也一直致力於開拓 Symvess 在肢體血管創傷領域的軍事市場。多家軍事治療機構已表示有興趣購買 Symvess。

To facilitate these purchases, we expect that Symvess will shortly be listed in the electronic catalog, or ECAT, which is an Internet system that provides the Department of Defense and other federal agencies with access to manufacturers' products.

為了方便這些採購，我們預計 Symvess 很快就會被列入電子目錄或 ECAT，這是一個網路系統，為國防部和其他聯邦機構提供存取製造商產品的權限。

As we've previously reported, due to the nature of the VAC process, we have consistently forecast that the majority of first year sales will occur in the second half of the year. We are pleased that the sales and the VAC activity to date is in line with our goals for this early period of market launch.

正如我們之前報導的那樣，由於 VAC 流程的性質，我們一直預測第一年的大部分銷售將發生在下半年。我們很高興看到，迄今為止的銷售和 VAC 活動符合我們在市場推出初期的目標。

The US commercial launch of Symvess this quarter was a major milestone for Humacyte, and we're excited to provide this transformative product to surgeons and patients in need of a new option to save limbs and lives.

本季 Symvess 在美國的商業發布是 Humacyte 的一個重要里程碑，我們很高興為需要新選擇來挽救肢體和生命的外科醫生和患者提供這種變革性產品。

Let me turn now to the ATEV indication that is our next priority, which is in dialysis access. As you'll recall, about six months ago, we reported top line results on our prospective randomized head-to-head V007 Phase III trial, which compared our vessel to the gold standard, which is autogenous fistula. This trial met its primary endpoints and showed superior patency at 6 and 12 months as compared to fistula.

現在讓我來談談我們的下一個優先事項——ATEV 指徵，即透析通路。您可能還記得，大約六個月前，我們報告了前瞻性隨機頭對頭 V007 III 期試驗的頂線結果，該試驗將我們的血管與金標準即自生瘻管進行了比較。該試驗達到了其主要終點，並顯示出與瘻管相比在 6 個月和 12 個月時具有更高的通暢性。

We were also able to identify 2 subgroups of patients who could benefit the most from the ATEV, which includes all women and men with diabetes and obesity. These two groups make up more than half of the dialysis access market. We believe that the efficacy and safety results in the subgroups, combined with the approximately 50% failure rate of standard-of-care in these vulnerable populations, means that they are important targets for the marketing of ATEV in dialysis access.

我們還能夠確定 2 個最能從 ATEV 中受益的患者亞組，其中包括所有患有糖尿病和肥胖症的女性和男性。這兩類族群佔據了透析通路市場的一半以上。我們認為，亞組的療效和安全性結果，加上這些脆弱人群中標準治療的失敗率約為 50%，這意味著他們是 ATEV 在透析通路行銷的重要目標。

We expect that the results from the V007 Phase III trial will be published in a major peer-reviewed medical journal in the near term.

我們預計 V007 第三階段試驗的結果將在近期發表在主要的同儕審查醫學期刊上。

We're also conducting an ongoing Phase III dialysis access trial in women, which has passed a major enrollment milestone. The V012 study is a small Phase III trial of 150 patients, which compares the efficacy and safety of ATEV to fistula for hemodialysis. A total of 84 patients has already been enrolled in the trial to date.

我們也正在對女性進行一項 III 期透析通路試驗，該試驗已通過了重要的招募里程碑。V012 研究是一項針對 150 名患者的小規模 III 期試驗，旨在比較 ATEV 與血液透析瘻管的療效和安全性。迄今為止，共有 84 名患者參加了該試驗。

An interim analysis for the V012 trial is planned for April 2026 when the first 80 patients will have reached the 12-month follow-up. Our plan is to submit a supplemental BLA in the second half of 2026, which includes data from the V012 and V007 Phase III pivotal studies, and to add AV access for hemodialysis as an indication for the ATEV.

V012 試驗的中期分析計畫於 2026 年 4 月進行，屆時首批 80 名患者將完成 12 個月的追蹤。我們的計劃是在 2026 年下半年提交補充 BLA，其中包括 V012 和 V007 III 期關鍵研究的數據，並將血液透析的 AV 通路添加為 ATEV 的適應症。

Finally, I'll briefly discuss some of our earlier-stage programs that we're also excited about, our small diameter ATEV for the treatment of coronary artery disease. During the first quarter, we announced plans to file an IND application with the FDA to allow first-in-human clinical testing of the small diameter acellular tissue engineered vessel, which is 3.5 millimeters in diameter rather than the 6-millimeter diameter of the approved Symvess conduit.

最後，我將簡要討論我們同樣興奮的一些早期項目，即用於治療冠狀動脈疾病的小直徑 ATEV。在第一季度，我們宣布計劃向 F​​DA 提交 IND 申請，以允許對小直徑無細胞組織工程血管進行首次人體臨床試驗，該血管的直徑為 3.5 毫米，而不是已獲批准的 Symvess 導管的 6 毫米直徑。

Our plans for IND filing in 2025 to support a first-in-human trial in coronary bypass are based on the outcome of a recent meeting held with the FDA. To date, only the 6-millimeter configuration of our vessel has been studied in human trials to include AV access for hemodialysis, trauma, and peripheral arterial disease.

我們計劃於 2025 年提交 IND 申請，以支持冠狀動脈繞道手術的首次人體試驗，這是根據最近與 FDA 舉行的會議的結果制定的。到目前為止，我們僅對 6 毫米結構的血管進行了人體試驗研究，包括用於血液透析、創傷和周邊動脈疾病的 AV 通路。

We're very pleased to be moving closer to human clinical studies of the small diameter ATEV in coronary artery bypass surgery, and we believe our planned IND filing and initiation of first-in-human study after FDA clearance will be another major milestone for Humacyte.

我們非常高興能夠更接近小直徑 ATEV 在冠狀動脈繞道手術中的人體臨床研究，我們相信，我們計劃的 IND 申請和 FDA 批准後啟動的首次人體研究將是 Humacyte 的另一個重要里程碑。

So we're off to a good start in 2025, and we look forward to sharing our continued progress with all of you as the rest of the year unfolds. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.

因此，我們在 2025 年有了良好的開端，我們期待在接下來的一年與大家分享我們不斷取得的進展。現在，我將把時間交給戴爾來審查我們的財務表現和其他業務發展。

Thank you, Laura. In March 2025, we completed a public offering that provided $46.7 million in net proceeds to Humacyte. Subsequent to the financing, in part due to current market conditions, we implemented a plan to reduce our workforce by approximately 31 employees. We also deferred additional new planned hires and reduced other operation expenses.

謝謝你，勞拉。2025 年 3 月，我們完成了公開發行，為 Humacyte 提供了 4,670 萬美元的淨收益。融資之後，部分由於當前的市場狀況，我們實施了一項計劃，裁員約 31 人。我們還推遲了額外的新招聘計劃並減少了其他營運費用。

These reductions have been done thoughtfully, and we've retained key personnel, resources, and initiatives to meet our corporate goals and milestones. We have undertaken these cost reductions to extend cash runway and better align our organizational structure with our top business objectives.

這些裁員是經過深思熟慮的，我們保留了關鍵人員、資源和舉措，以實現我們的企業目標和里程碑。我們採取這些成本削減措施是為了延長現金流，並使我們的組織結構更能與我們的最高業務目標保持一致。

These objectives include the commercial launch of Symvess, including sales, marketing and manufacturing; completion of the V012 Phase III pivotal trial on the ATEV in dialysis; and the planned filing of a supplemental BLA with the FDA and the filing of an IND to commence human study of the small diameter ATEV in coronary artery bypass grafting, or CABG.

這些目標包括 Symvess 的商業化發布，包括銷售、行銷和製造；完成透析中 ATEV 的 V012 III 期關鍵試驗；以及計劃向 F​​DA 提交補充 BLA 和提交 IND 以開始對冠狀動脈搭橋術（CABG）中的小直徑 ATEV 進行人體研究。

We estimate that we will incur aggregate charges representing onetime cash expenditures for severance and other employee termination benefits of approximately $800,000, of which the majority is expected to be incurred during the second quarter of 2025.

我們估計，我們將發生總計約 80 萬美元的遣散費和其他員工終止福利的一次性現金支出，其中大部分預計將在 2025 年第二季度發生。

We estimate a net savings due to the workforce reductions, operating cost reductions, and reduced capital expenditures, net of termination, severance, and benefits, totaling approximately $13.8 million in 2025. Net savings are estimated to be as much as $38 million in 2026 for a total estimated savings of over $50 million in 2025 and 2026 relative to our original forecast.

我們估計，由於裁員、降低營運成本和減少資本支出（扣除解僱費、遣散費和福利）而產生的淨節省額在 2025 年總計約為 1,380 萬美元。與我們最初的預測相比，2026 年的淨節省金額估計高達 3,800 萬美元，2025 年和 2026 年的總節省金額估計超過 5,000 萬美元。

Regarding the first quarter financial results, there was $517,000 in revenue for the first quarter of 2025, of which $147,000 related to the initial US commercial launch of Symvess in trauma. The remaining $370,000 in revenue resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications.

關於第一季財務業績，2025 年第一季的營收為 51.7 萬美元，其中 14.7 萬美元與 Symvess 在創傷領域的首次美國商業發布有關。剩餘的 37 萬美元收入來自與一家大型醫療技術公司的研究合作，旨在評估我們的生物工程人體組織在特定心血管和血管應用中的潛在用途。

There was no revenue for the first quarter of 2024. Cost of goods sold was $147,000 for the first quarter of 2025 and includes overhead related to unused production capacity, which was recorded as an expense during the first quarter. There was no cost of goods sold for the first quarter of 2024.

2024年第一季沒有收入。2025 年第一季的銷售成本為 147,000 美元，其中包括與未使用的生產能力相關的間接費用，該費用在第一季記錄為一項費用。2024 年第一季沒有銷售成本。

Research and development expenses for the first quarter of 2025 were $15.4 million, compared to $21.3 million for the first quarter of 2024. The decrease in 2025 expenses compared to the prior year result primarily from decreased material costs as we began capitalizing expenditures for inventory during the first three months ended March 31, 2025, following the commercial launch of Symvess, as well as a reduction in clinical study costs.

2025 年第一季的研發費用為 1,540 萬美元，而 2024 年第一季為 2,130 萬美元。2025 年費用與前一年相比有所減少，主要是因為在 Symvess 商業化推出後，我們在截至 2025 年 3 月 31 日的前三個月開始將庫存支出資本化，導致材料成本下降，以及臨床研究成本降低。

General and administrative expenses for the first quarter of 2025 were $8.1 million, compared to $5.3 million for the first quarter of 2024. The increase in 2025 expenses compared to the prior year period resulted primarily from the US commercial launch of Symvess in vascular trauma, including increased personnel expenses associated with the sales effort.

2025 年第一季的一般及行政費用為 810 萬美元，而 2024 年第一季為 530 萬美元。2025 年費用與去年同期相比有所增加，主要原因是美國在血管創傷領域推出了 Symvess 商業化產品，其中包括與銷售工作相關的人員費用增加。

Other net income for the first quarter of 2025 was $62.3 million, compared to a net expense of $5.3 million for the first quarter of 2024. The increase in 2025 of other net income compared to the prior year resulted primarily due to an increase in the noncash remeasurement of the contingent earnout liability associated with our August 2021 merger with Alpha Healthcare Acquisition Corp.

2025 年第一季的其他淨收入為 6,230 萬美元，而 2024 年第一季的淨支出為 530 萬美元。2025 年其他淨收入較前一年增加，主要是因為我們在 2021 年 8 月與 Alpha Healthcare Acquisition Corp 合併後，或有獲利負債的非現金重計量增加。

Net income was $39.1 million for the first quarter of 2025 compared to a net loss of $31.9 million for the first quarter of 2024. The increase in 2025 net income compared to the prior year period was primarily due to the increase in the noncash remeasurement of the contingent earnout liabilities described previously.

2025 年第一季淨收入為 3,910 萬美元，而 2024 年第一季淨虧損為 3,190 萬美元。2025 年淨收入與去年同期相比有所增加，主要是由於先前描述的或有盈利負債的非現金重計量增加。

We had cash, cash equivalents, and restricted cash of $113.2 million at March 31, 2025. Total net cash provided was $17.9 million for the first three months of 2025, compared to net cash provided of $35.1 million for the first 3 months of 2024. The net cash provided for the first three months of 2025 included the net proceeds from the March 2025 public offering.

截至 2025 年 3 月 31 日，我們的現金、現金等價物及受限現金為 1.132 億美元。2025 年頭三個月提供的總淨現金為 1,790 萬美元，而 2024 年前三個月提供的淨現金為 3,510 萬美元。2025 年頭三個月提供的淨現金包括 2025 年 3 月公開發行的淨收益。

The decrease in net cash provided during the first three months of 2025 compared to the prior year resulted primarily from the receipt of $20 million in proceeds under a draw from our funding arrangement with Oberland Capital, which occurred in 2024 but did not reoccur in 2025.

2025 年頭三個月提供的淨現金與前一年相比有所減少，主要原因是我們根據與 Oberland Capital 達成的融資協議提取了 2000 萬美元的收益，該收益發生在 2024 年，但 2025 年沒有再次發生。

With that, I will turn the call back over to Laura.

說完這些，我就把電話轉回給蘿拉。

Thank you, Dale. The approval and the launch of Symvess is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions to improve patient outcomes. Humacyte continues to deliver on our promises to physicians and patients. With our strong commercial execution, our promising pipeline programs, and our dedicated team, we're confident in our ability to continue (technical difficulty).

謝謝你，戴爾。Symvess 的批准和推出有力地證明了我們致力於提供真正變革性的再生醫學解決方案以改善患者治療效果。Humacyte 繼續履行我們對醫生和病人的承諾。憑藉我們強大的商業執行力、前景光明的管道項目以及我們敬業的團隊，我們有信心繼續（技術難度）。

Please stand by one moment. Once again ladies and gentlemen, we thank you for your patience. Please stand by. We will resume momentarily.

請稍等片刻。女士們，先生們，再次感謝大家的耐心等待。請稍候。我們將立即恢復。

(inaudible)

（聽不清楚）

You're now rejoined.

您現在已重新加入。

Hello operator, we're ready to take questions now.

您好，接線員，我們現在可以回答問題了。

(Operator Instructions) Ryan Zimmerman, BTIG.

（操作員指示）Ryan Zimmerman，BTIG。

Oh, thank you, can you hear me. Okay?

哦，謝謝，你聽得到我說話嗎？好的？

Yes, we can hear you.

是的，我們能聽到你的聲音。

Okay great thanks for taking the questions. Congrats on the first sales of Symvess. Maybe on those 3 sites that have purchased, Laura, I'd love to understand what their experience has been since they've purchased, whether you service those cases, how you're servicing those cases, et cetera.

好的，非常感謝您回答這些問題。恭喜 Symvess 首次銷售成功。蘿拉，也許在那 3 個已經購買的網站上，我很想了解他們自購買以來的體驗如何，你們是否為這些案例提供服務，你們如何處理這些案例，等等。

And then as we think about the uptake of Symvess this year, I appreciate your commentary about it being second half loaded. I'd love to understand how those 45 or so sites are running through the process and how you expect that maybe to translate into initial sales after you've now had a lot of back experience under your belt.

然後，當我們思考今年 Symvess 的吸收情況時，我很欣賞您關於其在下半年受到重視的評論。我很想了解這 45 個左右的網站是如何運作的，以及在您積累了大量經驗之後，您期望如何將其轉化為初始銷售額。

Well, I'll take the first part of the answer to this question, and then I'll ask our Commercial Officer, BJ Scheessele, to weigh in as well. So as far as the 3 commercial sites we have, we have performed our first implant.

好吧，我先回答這個問題的第一部分，然後我會請我們的商務官 BJ Scheessele 也來表達意見。就我們擁有的 3 個商業站點而言，我們已經進行了首次植入。

And at that particular site, our sales rep was able to be there for the implant. Although I will say that at many of the sites that have used the vessel before, having a sales rep in the OR is certainly not necessary. In addition to the clinical trial experience that a lot of surgeons have had, we have also been conducting hands-on training in hospitals where our sales executives have approached surgeons and VACs to get on the formulary.

在那個特定的地點，我們的銷售代表能夠到場進行植入。儘管我要說的是，在許多以前使用過該容器的站點，在手術室中設立銷售代表肯定是沒有必要的。除了許多外科醫生擁有的臨床試驗經驗之外，我們還在醫院進行實踐培訓，我們的銷售主管與外科醫生和 VAC 取得聯繫，以獲得處方集。

So it's certainly not necessary to have a sales representative in the OR for the initial cases, although sometimes we do, do that.

因此，對於初始病例，手術室裡肯定沒有必要安排銷售代表，儘管有時我們會這樣做。

As far as our experience with the VACs, we have had a fairly good conversion rate of VAC approvals. I would say that there was a little bit of a headwind that was imparted by the New York Times article, particularly during April, but that seems to be receding as the facts of the clinical experience become clearer to surgeons and to hospitals.

就我們與 VAC 合作的經驗而言，我們的 VAC 批准轉換率相當高。我想說的是，《紐約時報》的文章帶來了一些不利因素，尤其是在四月份，但隨著外科醫生和醫院對臨床經驗的事實越來越清楚，這種不利因素似乎正在消退。

And we also expect that publication of long-term data will also further improve our position there. The health economic model that we published in March is also a huge help because it shows pretty clearly that on a per patient basis, the total cost of the initial admission for patients who are treated with Symvess should be lower than the total cost of the initial admission for patients who are treated with a synthetic graft. And this is independent of any NTAP reimbursement.

我們也希望長期數據的發布也能進一步改善我們在那裡的地位。我們在三月發布的健康經濟模型也提供了巨大的幫助，因為它非常清楚地表明，按每位患者計算，使用 Symvess 治療的患者初次入院的總費用應該低於使用合成移植物治療的患者初次入院的總費用。這與任何 NTAP 報銷無關。

So I think that the growing number of publications and the growing factual story around the conduit is helping us get traction. But I'll let BJ weigh in here as well.

因此我認為，圍繞該管道的出版物數量和事實報告數量的不斷增加有助於我們獲得關注。但我也會讓 BJ 來參與。

No, Laura, I think you covered things well. Yes, Ryan, I would add that we're not only where those 3 institutions have acquired product, but even of the VAC submissions is a good mix of hospitals and surgeons that have known us, known us from our clinical studies, but others that have no experience with us. So I think that that's a good sign.

不，勞拉，我認為你把事情講得很好。是的，Ryan，我想補充一點，我們不只是這三家機構從我們這裡獲得了產品，而且 VAC 提交的產品中也包括一些醫院和外科醫生，他們認識我們，從我們的臨床研究中了解我們，但也有一些人沒有與我們合作過。所以我認為這是一個好兆頭。

And in terms of the VAC submissions and the sales funnel, feeling good about that, we're laying the groundwork now. We have a full sales funnel with the 45 submissions. We continue to add those on a regular basis. As Laura mentioned, we had some quick wins.

就 VAC 提交和銷售管道而言，我們對此感到滿意，我們現在正在奠定基礎。我們有一個包含 45 份提交的完整銷售管道。我們會繼續定期添加這些內容。正如勞拉所提到的，我們取得了一些快速的勝利。

On the other side, absolutely, the New York Times article with a couple of the VACs, some pushback for us that we've now had to respond to, to get back on track. I think also the tough economic environment we're in has pushed out some of the VAC reviews and added in additional financial reviews. Under to bring in a new product to market.

另一方面，《紐約時報》的文章中確實有幾篇關於簽證豁免的報道，這對我們來說是一種阻力，我們現在必須對此作出回應，才能回到正軌。我認為，我們所處的嚴峻經濟環境也推遲了一些 VAC 審查，並增加了額外的財務審查。將新產品推向市場。

We still see this as a three- to six-month VAC process for the majority of the ones that we're facing and that we've submitted to. And as Laura mentioned, the early feedback from those where we have had the formal VAC review, the conversion to approval has been strong now with the five approvals and obviously looking to build upon that.

對於我們面臨和提交的大多數案件，我們仍然認為這是一個需要三到六個月的 VAC 流程。正如勞拉所提到的那樣，根據那些已經接受過正式 VAC 審查的人的早期反饋，現在隨著五項申請獲得批准，批准的轉換率已經很高，顯然我們希望在此基礎上再接再厲。

So it's now building momentum currently, and we absolutely expect to see in the back half of the year the full impact of that.

因此，它目前正在積聚勢頭，我們絕對希望在今年下半年看到它的全部影響。

Yeah, that's very helpful and I appreciate that and on the ECAT and some of the government hospitals or the federal hospitals, whatever you want to call them, is the process similar? I'm curious, once you get on the ECAT, can VA hospitals, or whoever within that, order Symvess as needed? Or is there more hurdles to go through on that side of things?

是的，這非常有幫助，我對此表示感謝。 ECAT 和一些政府醫院或聯邦醫院（無論您想如何稱呼它們）的流程是否相似？我很好奇，一旦你進入 ECAT，VA 醫院或其中的任何人是否可以根據需要訂購 Symvess？或者說，在這方面還存在更多障礙需要克服？

Well again

再好不過了

Oh, go ahead.

噢，繼續吧。

I'm sorry. Yes, BJ, I'll ask you to weigh in, too. So the ECAT process, which we're nearing completion on, does technically allow military hospitals and VAs to order the product. However, typically, certainly in military institutions, there also has to be surgeon champions.

對不起。是的，BJ，我也請你參與。因此，我們即將完成的 ECAT 流程在技術上確實允許軍事醫院和 VA 訂購該產品。然而，通常情況下，當然在軍事機構中，也必須有外科醫生冠軍。

Certainly, we've -- in addition to working with civilian hospitals, as I mentioned, our sales executives have been working closely with some military institutions. And we, in fact, have previous relationships in some military care facilities who participated in our clinical trials and our compassionate use cases.

當然，正如我所提到的，除了與民間醫院合作之外，我們的銷售主管還與一些軍事機構密切合作。事實上，我們之前與一些軍事護理機構有過合作關係，他們參與了我們的臨床試驗和同情用例。

So we are building out that sort of surgical support for the product. Military hospitals tend not to have a formal VAC process. I'm not sure if that's true in all cases.

因此，我們正在為該產品建立這種手術支援。軍隊醫院往往沒有正式的 VAC 流程。我不確定這是否在所有情況下都是正確的。

But really having surgeon champions and being on the -- having the correct distribution and being on the ECAT are really key inputs there. And I'll let Dale -- I'm sorry, I'll let BJ correct me where I'm wrong.

但真正擁有外科醫生冠軍和正確的分佈以及 ECAT 才是真正的關鍵投入。我會讓 Dale — — 對不起，我會讓 BJ 糾正我的錯誤。

No, I think that's exactly right. In parallel with building surgeon advocacy, which we -- back to clinical studies, to our sales efforts, you obviously absolutely have to jump through those procurement hoops, and soon getting on the ECAT is going to be a big milestone and ability to order. And yes, we've been fortunate, we've actually been working with an outside DoD procurement partner to help in that regard, given their expertise and connection. So I think that gives you a sense of where we're at in this particular.

不，我認為完全正確。在建立外科醫生倡議的同時，我們——回到臨床研究，回到我們的銷售工作，你顯然必須跳過那些採購環節，很快進入 ECAT 將是一個重要的里程碑和訂購能力。是的，我們很幸運，事實上，我們一直在與國防部外部採購合作夥伴合作，利用他們的專業知識和人脈來提供協助。所以我認為這能讓你了解我們目前所處的具體情況。

That's very helpful, BJ, and just last one I'll sneak it in. Do you have to expand the sales force? Or can you service the military hospitals with your existing sales force right now, as well as the 200 or so Level 1 trauma centers?

這非常有幫助，BJ，最後一個我會偷偷地把它放進去。您是否需要擴大銷售團隊？或者您現在能否利用現有的銷售隊伍為軍事醫院以及大約 200 個一級創傷中心提供服務？

Yes. I would say now our current sales force feel comfortable being able to cover the sales targets for the geographies that we have, those hospitals, and submitting to those VACs. And again, you kind of get a sense of the full sales pipeline.

是的。我想說，現在我們現有的銷售團隊可以輕鬆完成我們所在地地區、醫院以及 VAC 的銷售目標。再次，您可以了解整個銷售管道。

And then, certainly, [early interest] from the military treatment facilities match up well with where we have our sales reps and sales force deployed. I think as we increase success, both civilian and military, we'll look to add to our sales force at that time.

當然，軍事治療機構的早期興趣與我們部署銷售代表和銷售人員的地方非常吻合。我認為，隨著我們在民用和軍用領域取得更大的成功，我們將會尋求擴大我們的銷售團隊。

Okay, thanks for taking my question.

好的，感謝您回答我的問題。

Josh Jennings, TD Cowen.

喬許‧詹寧斯 (Josh Jennings)，TD Cowen。

Congrats on the progress with the US Symvess launch. Laura and Dale, you guys were gracious enough on the last earnings call to just comment on where Street estimates stood for 2025. And just wanted to check back in after the last 1.5 month of the experience and the progress you've made. Do those estimates still seem reasonable or in the ballpark of kind of the internal expectation for the revenue ramp here?

祝賀美國 Symvess 發布取得進展。勞拉和戴爾，你們在上次收益電話會議上非常慷慨地評論了華爾街對 2025 年的預測。只是想在過去 1.5 個月的經歷和取得的進展之後再回來查看。這些估計是否仍然合理或大致符合這裡收入成長的內部預期？

I think we remain in the same place with our expectations, but I'll let Dale comment further.

我認為我們的期望仍保持不變，但我會讓戴爾進一步評論。

Yeah, I agree. I think we gave some guidance, Josh, on the first -- I'm sorry, it seemed like a first quarter call, but that was our year-end call that happened in March. Based on the traction we're seeing, the number of hospitals that are involved in the VAC process, as BJ mentioned, we're still comfortable with the guidance. And again, as Laura mentioned earlier in the call, due to that VAC ramp, we expect most of those revenues to come in, in the second half. But we're not seeing anything currently that would suggest we need to move off those estimates.

是的，我同意。喬希，我想我們首先給了一些指導——抱歉，這看起來像是第一季的電話會議，但那是我們三月召開的年終電話會議。根據我們所看到的進展，以及參與 VAC 流程的醫院數量，正如 BJ 所提到的，我們仍然對指導感到滿意。正如勞拉早些時候在電話會議中提到的那樣，由於 VAC 的增長，我們預計大部分收入將在下半年實現。但我們目前沒有看到任何跡象表明我們需要放棄這些估計。

And just wanted to ask about V012 and you guys are enrolling that nicely. I was hoping for just a review on in terms of how the clinical development team or your team has applied the learnings from other Phase III studies. Clearly in the patient selection and the subgroups you guys are going after is one. But just I think, what are the learnings that are being applied? Anything from just the procedural technique to anything else that you want to comment on in terms of helping us think about the potential for success for V012?

只是想問一下關於 V012 的問題，你們註冊得很順利。我希望對臨床開發團隊或您的團隊如何應用其他 III 期研究的經驗進行回顧。顯然，在患者選擇和你們所追求的亞群方面就是其中之一。但我只是在想，正在應用哪些學習成果？從程式技術到其他任何您想評論的內容，以幫助我們思考 V012 成功的可能性嗎？

Yeah, Josh. So we certainly have -- we've treated a lot of dialysis patients. And as you know, this is a complicated and sick population, and we have benefited from our prior clinical experience. So there are a couple of key outputs that I think we're following. One is, it's not just that the surgical implantation of the conduit. What happens to the conduit in the dialysis center and in the hands of various interventionalists for these patients is very important to the outcome of the study.

是的，喬希。所以我們確實已經治療了很多透析患者。正如你們所知，這是一個複雜且病情嚴重的群體，我們從先前的臨床經驗中受益匪淺。因此，我認為我們正在遵循幾個關鍵的輸出。一是，這不僅僅是透過手術植入導管。透析中心的導管以及這些患者的各種介入醫師手中的情況對於研究結果非常重要。

And so we're paying close attention to how the dialysis centers are handling the conduit and how the dialysis centers are adhering to the clinical trial protocol. And we're doing the same thing with interventionalists because our surgeons do a great job of sewing the vessel in.

因此，我們密切注意透析中心如何處理導管以及透析中心如何遵守臨床試驗方案。我們對介入科醫生也做了同樣的事情，因為我們的外科醫生在縫合血管方面做得非常出色。

But what's important for the execution of the clinical trial is that we follow up on these later healthcare providers who are also working with patients. So we're paying a lot of attention to that. And again, I think that the female population struggle so poorly -- struggle so much with fistula, we do anticipate that the results of this trial will be positive.

但對於臨床試驗的執行來說，重要的是我們要跟進這些後來也與病人合作的醫療保健提供者。所以我們非常關注這一點。而且，我認為女性群體在與瘻管的鬥爭中表現得非常糟糕——我們確實預期這次試驗的結果將是正面的。

Great. Maybe just one follow-up on the access indication. Just in terms of the partnership with Fresenius, the investment there, have there been any changes? And then I guess the second layer is how involved are they in the V012 and in terms of the design of the trial, anything else that you can share?

偉大的。也許只是對訪問指示進行一次跟進。就與費森尤斯的合作關係以及投資而言，有什麼改變嗎？然後我想第二層是他們參與 V012 的程度如何，以及就試驗設計而言，您還有什麼可以分享的嗎？

Yeah, So the partnership with Fresenius remains strong. I think that the Fresenius leadership, we're particularly encouraged by the wonderful results that we had in V007. Fresenius is also fully aware that women, in particular, but also patients with obesity and diabetes, not only have trouble with their access, but they're very expensive to care for.

是的，因此與費森尤斯的合作關係仍然牢固。我認為費森尤斯領導階層對我們在 V007 中取得的出色成績感到特別鼓舞。費森尤斯也充分意識到，尤其是女性，以及肥胖和糖尿病患者，不僅難以獲得治療，而且治療費用非常昂貴。

And in some cases, Fresenius, as a holistic healthcare provider for these patients, has to bear those costs. So as I think I've mentioned in previous calls, we have been working with Fresenius to quantify the added costs that are incurred in patients who have an access that isn't working or in patients who are forced to remain on catheter. And those costs are significant, and we believe there's going to be a strong health economic case.

在某些情況下，費森尤斯作為這些患者的整體醫療保健提供者，必須承擔這些費用。因此，正如我在之前的電話會議中提到的那樣，我們一直在與費森尤斯合作，量化那些無法正常工作的患者或被迫繼續使用導管的患者所產生的額外費用。這些成本是巨大的，我們相信這將具有強大的健康經濟意義。

I think I also pointed out on the last call that dialysis access centers used to be penalized for not having a sufficient number of fistulas, but the reimbursement penalty now has been altered so that if centers have too many patients on catheter, their reimbursement is penalized. And so I believe that Symvess in the dialysis access space, which has the potential to get so many patients off of catheter really aligns with the reimbursement objectives and the business objectives of Fresenius.

我想我在上次電話會議上也指出過，透析中心過去常常因為沒有足夠數量的瘻管而受到懲罰，但現在報銷懲罰已經改變，如果中心有太多患者使用導管，他們的報銷就會受到懲罰。因此，我相信，透析通路領域的 Symvess 有可能讓許多患者擺脫導管，這與費森尤斯的報銷目標和業務目標完全一致。

Kluska from Cantor Fitzgerald.

康托·菲茨杰拉德的克魯斯卡。

Hi, good morning, everybody. At your Analyst Day two months ago, you gave us a very early review, and we heard from some surgeons directly. So now that you've added about 20 more hospitals since that time, I'm just curious on the VAC questioning, if you're hearing that it's fairly consistent. It sounded like at that event that the surgeons were alluding that it was pretty straightforward. Sometimes they were asking about how often the products would be used and cost. But has anything changed since you've added more hospitals?

大家好，早安。在兩個月前的分析師日上，您給了我們一個非常早期的評論，我們直接聽取了一些外科醫生的意見。因此，從那時起您已經增加了大約 20 家醫院，我只是對 VAC 質詢感到好奇，如果您聽說它相當一致。聽起來，在那次活動中，外科醫生暗示這很簡單。有時他們會詢問產品的使用頻率和價格。但是自從增加了更多醫院之後，有什麼改變嗎？

Yeah, I'll let BJ answer this as well. But I would say that, no, the dialogue and the talk track is pretty similar. The clinical data that we published in JAMA Surgery in November are very strong. And the label is really not -- I mean, that just doesn't come up as an issue very often.

是的，我也請 BJ 回答這個問題。但我想說，不，對話和談話軌道非常相似。我們 11 月在 JAMA Surgery 上發表的臨床數據非常強勁。而標籤實際上並不是——我的意思是，這並不經常成為一個問題。

We do have to talk about the price point. And so leveraging our published Budget Impact Model that came out in March, I think, is going to continue to be important. When we get in front of VACs and when we present the Budget Impact Model, our success rate is very high. BJ, do you have anything to add?

我們確實需要討論價格問題。因此，我認為，利用我們三月發布的預算影響模型將繼續發揮重要作用。當我們面對 VAC 並展示預算影響模型時，我們的成功率非常高。BJ，您還有什麼要補充的嗎？

No, I think that covers it well. Yes, strong clinical belief and understanding based not only our clinical data, but their personal experience, questions on price value. But again, as Laura mentioned, our published BIM and the data from that, again, showing that the cost to offset fewer infections, fewer amputations, more than offset the upfront cost of our product versus a synthetic or versus an allograft or a xenograft.

不，我認為這已經很好了。是的，強烈的臨床信念和理解不僅基於我們的臨床數據，還基於他們的個人經驗和對價格價值的疑問。但是，正如勞拉所提到的那樣，我們發布的 BIM 及其數據再次表明，與合成、同種異體移植或異種移植相比，減少感染、減少截肢的成本足以抵消我們產品的前期成本。

And then I think just the other piece of the equation is, obviously, we're working on our NTAPs. And so the proposed ruling was put out by CMS.

然後我認為等式的另一個部分顯然是我們正在研究我們的 NTAP。因此，CMS 提出了擬議的裁決。

We're in the process of putting our response back due mid-June, and then ultimately you hear in August, and then hopefully enacted in October. So that's obviously a piece of the equation, too, the incremental reimbursement part of the NTAP and the follow-on effect with private insurers.

我們正在將答复推遲到 6 月中旬，最終預計在 8 月收到答复，並希望在 10 月頒布。因此，這顯然也是等式的一部分，即 NTAP 的增量報銷部分以及私人保險公司的後續影響。

Thanks so much and of the 45 hospitals, can you give us a sense of roughly what percent of them were involved in your clinical trials and have prior experience?

非常感謝，您能否告訴我們，在這 45 家醫院中，大約有多少百分比參與了您的臨床試驗並擁有相關經驗？

Yeah, it's interesting. I would say it's actually the minority, so less than 50%, we'd have to look up exactly what that is. And so, yes, back to my earlier point, I think there was a lot of understanding and visibility both from publications, the clinical data, the approval, industry conferences, medical education and events that we've held that brought visibility to what we are doing, that gave us a jumpstart when we went into these institutions.

是的，很有趣。我想說這實際上是少數，所以少於 50%，我們必須找出到底是多少。是的，回到我之前的觀點，我認為從出版物、臨床數據、批准、行業會議、醫學教育和我們舉辦的活動中獲得了大量的理解和關注，這些都讓我們所做的事情更加引人注目，讓我們在進入這些機構時獲得了先機。

And then obviously, our sales force, through their relationships and being able to communicate the clinical and economic value have brought these surgeons, advocates, and hospitals along through the VAC process. So a good mix and knowing that, that's going to be important going forward because you work through those that you know, but the majority do not and feel good about our conversion rate at this point.

顯然，我們的銷售人員透過他們的關係以及能夠傳達臨床和經濟價值，帶領這些外科醫生、倡導者和醫院完成了 VAC 流程。因此，良好的組合和了解這一點對於未來發展至關重要，因為您要處理那些您知道但大多數人不知道的問題，並且對我們目前的轉換率感到滿意。

The next question comes from Bruce Jackson with Benchmark Company.

下一個問題來自 Benchmark Company 的 Bruce Jackson。

Hi, good morning and thank you for taking my questions. I was hoping to get a little color around the surgeon adoption patterns at the accounts using the product. So usually, you get the surgeon advocate champion who starts doing the first procedures and then the other doctors will follow along. So do you have any anecdotal information on how that's going?

大家好，早安，感謝您回答我的問題。我希望能夠從使用該產品的帳戶中了解外科醫生的採用模式。因此，通常情況下，你會得到一位外科醫生倡導者，他會先進行第一項手術，然後其他醫生會跟進。那麼，您有什麼關於此事進展的軼事資訊嗎？

Well, it is truly anecdotal, Bruce. We do have a vascular surgeon who is actually new to the product, who treated a patient at one of our commercial sites and said he had a great experience and, was looking forward to using the product again.

嗯，這確實是軼事，布魯斯。我們確實有一位血管外科醫生，他實際上是該產品的新手，他在我們的一個商業站點治療了一位患者，並表示他獲得了很好的體驗，並期待再次使用該產品。

But you're right, I think that in most institutions, this will start with 1 or 2 surgeons and then move outward. There's always an early adopter in every crowd, and those are probably the first surgeons who we'll work with.

但您說得對，我認為在大多數機構中，這將從 1 或 2 名外科醫生開始，然後向外擴展。每個人群中總會有一個早期採用者，而這些人很可能就是我們合作的第一批外科醫生。

Okay great and then. Oh go ahead go-ahead Bruce.

好的，太好了。哦，繼續吧，布魯斯。

Oh yeah, no, I would just add, and it's also a mix between vascular surgeons and trauma surgeons, ultimately more vascular than trauma, but trauma, obviously, in some ways, see these patients can be first and also influence on being able to not only treat these patients, but bring in new technologies into the hospital.

哦，是的，不，我只想補充一點，這也是血管外科醫生和創傷外科醫生的混合體，最終血管外科醫生比創傷外科醫生更擅長，但創傷外科醫生顯然在某些方面可以首先看到這些病人，並且不僅能治療這些病人，還能將新技術引入醫院。

So I think we see it as a mix of that. Wherever we get the traction, I think we're able to port over to that other group, be it if you start with a vascular to go to a trauma or trauma go to a vascular. Again, it's early, but we've seen the ability to get that message with one group to the other group and then obviously build upon interest from there.

所以我認為我們認為這是兩者的混合體。無論我們在哪裡獲得牽引力，我認為我們都能夠移植到其他群體，無論是從血管開始到創傷還是從創傷到血管。再說一次，現在還為時過早，但我們已經看到了將一個群體的訊息傳遞給另一個群體的能力，然後顯然從那裡建立興趣。

Okay, great. And then a question on the pipeline. Is there anything new on the BioVascular pancreas or any upcoming data?

好的，太好了。然後是關於管道的問題。BioVascular 胰臟方面有什麼新進展或即將公佈的數據嗎？

Yes. We have continued primate implants in the BioVascular pancreas. We're also continuing laboratory experiments. I don't have anything new explicitly to report now as compared to our last call six weeks ago, but we are going to publish preclinical results probably later this year.

是的。我們繼續在 BioVascular 胰臟中進行靈長類動物植入。我們還在繼續進行實驗室實驗。與六週前的上次電話會議相比，我現在沒有任何新的內容可以明確報告，但我們可能會在今年稍後發布臨床前結果。

Okay, great. Thank you very much you got it.

好的，太好了。非常感謝您收到了它。

Thank you. At this time, I would like to turn the call back over to management for closing comments.

謝謝。現在，我想將電話轉回給管理階層，徵求他們的最後意見。

Yes. Thank you, operator. This has been a great opportunity to share our progress. These are exciting times in the world, as we all know. And with all of the flux going on in the economic markets and in the healthcare markets, we're pleased that despite all of that, we are getting important and substantial traction at Level 1 trauma centers with our first commercial launch. So our fabulous commercial team will continue to work this, and we anticipate more good news going forward. So thank you for your time.

是的。謝謝您，接線生。這是一個分享我們進展的絕佳機會。眾所周知，這是世界激動人心的時刻。儘管經濟市場和醫療保健市場瞬息萬變，但我們很高興看到，儘管如此，我們的首次商業發布仍在 1 級創傷中心獲得了重要且實質的推動力。因此，我們出色的商業團隊將繼續努力，我們期待未來有更多好消息。感謝您抽出時間。

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

謝謝。今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與，祝您有個愉快的一天。